Occupational and educational eye and face protection. NIOSH [1990b]. Department of Health and Human Services. Examples of these standards include standards for chemical exposure, bloodborne pathogens, and slips, trips, and falls. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. For drug administration by a route that is likely to result in leakage, the location should be prepared with plastic-backed absorbent pads, and locking connections should be used if possible. [http:// nioshdev.cdc.gov/niosh/docs/2010-167]. Other organ systems suggested from the medical history should also be assessed. The authors chose to test "elimination type" solutions (cleaners), whose main action is to dissolve chemical products on the surface, and "degradation type" (deactivating) solutions, which react with the chemical structure of compounds leading to their degradation and, possibly, the formation of expected non-cytotoxic compounds. Int Arch Occup Environ Health 64:105112. Discuss how knowledge of the timing and amounts involved can aid the planning process. C.). The drug may then be transferred to an IV bag or bottle. Risk Factors for Sleep Apnea The importance of human data in the establishment of occupational exposure limits. These bags should be sealed and then discarded. Sodium hypochlorite solution, detergent, neutralizer and rinsing have been shown to be effective on hard surfaces (Touzin, 2010). Lyon, France. CETA (Controlled Environment Testing Association) [2008]. Such area should contain a Containment Primary Engineering Control that meets the specifications of USP <797>. After use, gloves and gowns should be disposed of in designated HD waste containers (NIOSH, 2004). Similar restrictions are included in ASHP's 1990 publication, USP <797> (since its revision in 2008), and USP <800> (ASHP, 1990; USP 797, 2012; USP 800, 2016). Containment Ventilated Enclosure (CVE) - A C-PEC used for manipulation of non-sterile HDs. 2014-138]. Devices that do not lock on and may be transferred from one vial to another may increase the release of HD contamination (ASHP, 2006). When designating a drug as hazardous, professionals trained in pharmacology and toxicology have historically considered several factors (McDiarmid, 1991) that are similar to the considerations used in NIOSH's approach, including: In addition to publishing the 2004 Alert on HD safe handling, NIOSH biennially updates their HD list to reflect newly Food and Drug Administration (FDA)-approved agents, and also to address any listings which may be modified in light of newly published scientific literature or other governmental agency determinations. Handbook of Cancer Chemotherapy. Presently working as a college lecturer at the department of Fire Safety Engineering & Management at International College of Engineering & Management, Muscat, Oman. [http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm]. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Socie G, Henry-Amar M, Cossett JM, Devergie A, Girinsky T, Gluckman E [1991]. Laboratory decontamination and destruction of carcinogens in laboratory wastes: Some antineoplastic agents. The Safety Plan should be reviewed annually, updated as necessary, and evaluated for effectiveness. The examining physician should consider the reproductive status of employees and inform them regarding relevant reproductive issues. Safe handling is required for all HDs no matter how they are used. In the United States, the Occupational Safety and Health Administration (OSHA) sets the standard for workplace safety. Biological monitoring and medical surveillance of workers exposed to antineoplastic agents. The exhaust air is treated by double HEPA filtration or single HEPA filtration/incineration. The National Institute for Occupational Safety and Health (NIOSH) estimates that somewhere around 8 million HCWs are potentially exposed (NIOSH, 2009). Q47. Morgantown, WV: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health, Fatal Accident Circumstances and Epidemiology (FACE) Report No. Biological Safety Cabinet (BSC) - A ventilated cabinet for CSPs, personnel, product, preparation, and environmental protection having an open front with inward airflow for personnel protection, downward high efficiency particulate air (HEPA) filtered laminar airflow for product and preparation protection, and HEPA filtered exhausted air appropriately removed by properly designed building ventilation for environmental protection. The C-PECs generally used for handling HDs require personal protective equipment (PPE) to provide a barrier between the worker and the HD during episodes of potential contact, and OSHA requires employers to provide and to require the use of PPE that protects employees against the hazards to which they are exposed [29 CFR 1910.132]. Occupational Safety and Health Administration and the Joint Commission. NABP (National Association of Boards of Pharmacy) [2014]. To protect against electrical shock injury in the event of contact between a crane and an energized line, the CSA recommends the following: The five cases presented here were investigated by the NIOSH FACE Program between March 1990 and March 1993. Pedersen-Bjergaard J, Andersen MK, Christiansen DH, Nerlov C [2002]. Food and Drug Administration. (Harrison, 1996). European Journal of Oncology Nursing, 13(5), 368-375. Examination and laboratory evaluation should be guided by the individual's history of exposures and follow the outline of the periodic evaluation. [DHHS (NIOSH) Publication No. This training should include didactic overview of HDs, including mutagenic, teratogenic, and carcinogenic properties, and it should include ongoing training for each new HD (USP 800, 2016). 2005-100. HDs should be dispensed in the final dose and form whenever possible (ASHP, 2006). During cleaning, the worker should wear PPE similar to that used for spills. Hon CY, Chua PPS, Danyluk Q, Astrakianakis G [2014a]. Nurses' use of hazardous drug-handling precautions and awareness of national safety guidelines. Exposure in susceptible individuals can lead to asthma or allergic contact dermatitis (Kusnetz and Condon, 2003). Respirators should be available near the spill kits. Spivey S, Connor TH [2003]. ", (https://edit.osha.gov/laws-regs/standardinterpretations/2005-02-08-0.). Investigational new drugs should be prudently handled as HDs unless adequate information becomes available to exclude them. Ann Arbor: National Sanitation Foundation. The FDA's 510(k) process does not establish independent performance standards for devices submitted as "substantially equivalent." ASHP's Recommended General Spill Procedures (ASHP, 2006), ASHP's Recommended Procedures for Spills in a C-PEC (ASHP, 2006). NIOSH also recommends establishing procedures and providing training for handling HDs safely, cleaning up spills, and using all equipment and PPE properly. The program must also include the following: A list of the covered HDs known to be present using a product identifier that is referenced on the appropriate SDS. Safe handling of hazardous drugs. Wipe the neck with sterile alcohol and allow it to dry. Washington, DC: U.S. Government Printing Office, Office of the Federal Register. Employees are able to take quizzes on the quizlet website to test their knowledge of workplace safety. Waste containers stored inside the C-PEC should be sealed and decontaminated before removing from the C-PEC for discard, due to the potential HD contamination on the outside of the container (ASHP, 2006). Nygren O and Aspman O [2004]. 8-1.1. Boiano JM, Steege AL, Sweeney MH. CA, Cancer J Clin 56:354-365. 297. Type A2 cabinets have a higher inflow velocity, have recirculated air within the cabinet similar to the A1 and may exhaust HEPA filtered air back into the work area or to the environment through properly functioning exhaust canopies, and have all contaminated ducts and plenums under negative-pressure or surrounded by negative-pressure ducts and plenums. NIOSH List of antineoplastic and other hazardous drugs in healthcare settings. OSHA also sets standards for whistleblower protections, which protect workers who report unsafe working conditions. Syringe size should be large enough so that they are only 3/4 full when containing the entire drug dose to prevent loss of the plunger during manipulation and to allow space to manage the dose. Use eye and face protection when compounding a drug outside a C-PEC (e.g., in the operating room), working at or above eye level, cleaning a BSC or CACI, or cleaning a spill; Use face shields in combination with goggles to provide a full range of protection against splashes to the face and eyes; Face shields alone do not provide full eye and face protection; Eyeglasses with temporary side shields are inadequate protection to the eyes from splashes; A full-facepiece respirator also provides eye and face protection; and. The carcinogenicity of anticancer drugs: a hazard to man. IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans: Pharmaceutical Drugs. The employee's exposure levels or anticipated exposure levels, which may include estimates of frequency and/or duration of HD handling. In the thirty years since the publication of OSHA's technical guidance on HD safe handling, the scientific literature on this topic has grown tremendously. The American College of Occupational and Environmental Medicine also suggests that a risk assessment be made and alternative reassignment be considered for HD handlers during these vulnerable periods (ACOEM, 2011). Jan 2019 - May 20195 months. Make these kits available near all potential sources of exposure. Even prior to drug compounding, exposure opportunity exists for oncology workers, as studies have documented that drug contamination can occur from handling the outside of new, unopened drug vials (Connor, 2005; Nygren, 2002a; Sessink, 1992a; Power, 2014). USP's drug standards are enforceable in the United States by the Food and Drug Administration. The authors did not report using detergent or neutralizer with this bleach solution. 91-21. Compounding of non-sterile HDs should meet the recommendations of the NIOSH Alert and USP <795> and USP <800> (NIOSH, 2004; USP 795; 2013; USP 800, 2016). Any operation/procedure in their work area where drugs that present a hazard are present; The location and availability of the written hazard communication program; The location and availability of the list(s) identifying HDs present in the work area; and. Disposal of the waste bag should follow HD disposal requirements. Each participant ( N = 100) was randomly assigned to one of two conditions. HDs and contaminated materials should be disposed of in accordance with federal, state, and local laws. For example, a Danish study of female pharmacy technicians found a statistically significant increased risk of non-Hodgkin's lymphomas (Hansen, 1994), a cancer seen in excess in cancer patients following certain therapies (Krishnan and Morgan, 2007). If a C-PEC (BSC or CACI) is unavailable, for example, in a private practice office, accepted practice is the sharing of a cabinet (e.g., several medical offices share a cabinet) or sending the patient to a center where HDs can be prepared in a C-PEC. In compliance with the HCS [29 CFR 1910.1200] (OSHA, 2012b), all personnel involved in any aspect of the handling of HDs (physicians, nurses, nursing assistants, pharmacists, pharmacy technicians, housekeepers, and other employees involved in receiving, transport, storage, compounding, administering, waste handling and other forms of handling) must receive information and training to apprise them of the hazards of HDs present in the work area. Surgical masks do not provide adequate protection (NIOSH, 2004). Once fully garbed, contain spill using spill kit. Evaluate jobsites before beginning work to determine the safest areas for material storage, the best placement for machinery during operations, and the size and type of machinery to be used. When cleaning C-PECs, one must ensure that they appropriately rinsed, and that the cleaning and rinsing materials are collected and disposed of as contaminated waste. All HDs should be labeled and identified to prevent improper handling. ACOEM (American College of Occupational and Environmental Medicine) [2011]. OSHA has long recognized that the implementation of a safety and health program is a way of _____ A. Individual 's history of exposures and follow the outline of the federal Register and awareness of safety! Protections, which may include estimates of frequency and/or duration of HD handling, local... 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